Device product
LUMBAR PUNCTURE TRAY ADULT 18G X 3.5
Z-0795-2022
Product summary
- Event
- Event 89553
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,630 devices
- Official record key
device-enforcement:Z-0795-2022
Official wording
Reason: Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Code information: Catalog Number: 4303C Lot Numbers/UDI (GTIN, DI + PI): 0001411294 (01)10885403057021(17)220331(10)0001411294 0001414259 (01)10885403057021(17)220331(10)0001414259 0001414361 (01)10885403057021(17)220331(10)0001414361 0001415025 (01)10885403057021(17)220430(10)0001415025 0001417547 (01)10885403057021(17)220430(10)0001417547 0001422377 (01)10885403057021(17)220630(10)0001422377 0001425366 (01)10885403057021(17)220630(10)0001425366 0001426588 (01)10885403057021(17)220630(10)0001426588 0001428500 (01)10885403057021(17)220630(10)0001428500 0001431408 (01)10885403057021(17)220630(10)0001431408 0001433267 (01)10885403057021(17)220831(10)0001433267 0001433868 (01)10885403057021(17)220930(10)0001433868
Distribution pattern: U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.
Derived failure modes
-
Unknown
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.